Associate Supplier Quality, EMEA

This is where you save and sustain lives

At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.

Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.

Associate Supplier Quality EMEA

Role Summary:

• Independently manage Supplier Quality Assurance and Maintenance activities for assigned suppliers
• Supplier quality assessment and follow-up of supplier failures and low performers
• Lead activities such as execution of quality assessments/audits negotiation and implementation of Quality Agreements and monitoring and reporting of metrics.
• Manage quality and compliance-related issues between suppliers and Baxter. Perform Supplier audits.

Essential Duties and Responsibilities:

• Set Quality system requirements to suppliers within the employees defined commodity portfolio.
• Perform Qualification of suppliers to medical device pharmaceutical combination devices and/or biologics standards and oversee their placement on the Approved Supplier List (ASL) including ensuring the creation and maintenance of supporting evidence (Supplier Master File).
• Conduct and oversee supplier audits- qualification and re-qualification including finding closure.
• Oversee and negotiate Quality Agreements between suppliers and Baxter.
• Assess and process changes induced by the supplier and/or Baxter.
• Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures; Collect trend and report supplier quality metrics.
• Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.
• Manage and oversee Purchasing controls CAPA including root cause identification and effective and timely closure.
• Develop and/or deliver training to internal teams and suppliers.
• Execute SCAR management when needed effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed. Accountable for NCR (non-conformance reports) as assigned conducting NCR timeliness and effectiveness reviews and trending for actions.
• Support the Manufacturing Regulatory Quality and purchasing organization for third-party suppliers related activities as applicable

Qualifications:

• Experience in Supplier Quality Management.
• Strong quality orientation required.
• 5 years experience in Quality Supplier Quality Manufacturing Engineering or related field
• Knowledge of pharmaceutical and/or medical device regulations e.g. ISO 13485 ISO 9001 FDA cGMP international cGMP MDD MDR Eudralex
• Auditing skillsets up to and including certified SQ lead auditor training; Quality Management System auditing
• Collaboration and Teamwork: effective communicator at all levels both internally and externally; excellent written oral and interpersonal communication and presentation skills
• Project management skills managing multiple issues of moderate to high complexity relatively independently
• Ability to manage the Quality relationship with assigned key suppliers
• Superior time-management skills
• Multi-tasking skills in a demanding fast-paced environment.

What we offer:

• The probation period is 3 months and then for an indefinite period.
• Competitive salary annual bonuses recognition award program.
• Corporate culture is based on our values: collaboration speed courage and simplicity.
• Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
• A package of benefits including Private medical care (Lux Med) Life Insurance and a Multisport card.
• Bax4U - cafeteria/lunch cards (300 PLN monthly).
• PPE program with very attractive conditions available for each employee after 3 months.
• Fully covered language courses (English or other languages according to business needs).
• Co-financing of holidays and an additional 2 days off from work annually and an extra day off for your birthday!
• Employee Stock Purchase Plan.
• Phenomenal Warsaw office location - Powile!

Baxter is committed to supporting the need for flexibility in the workplace. We achieve this through our flexible workplace policy which includes a required minimum number of days on-site each week. This policy provides the benefits of connecting and collaborating in person in support of our Mission. The flexible workplace policy is subject to local laws and legal its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race religion color national origin sex gender gender expression sexual orientation age marital status veteran status or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process perform essential job functions and receive other benefits and privileges of employment. Please get in touch with us to request an accommodation.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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